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Obesity, Childhood clinical trials

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NCT ID: NCT05711979 Terminated - Obesity, Childhood Clinical Trials

African American Resilient Caregivers

AARC
Start date: February 7, 2023
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to test the feasibility of a virtual intervention to prevent child obesity and cardiovascular disease in African American families.

NCT ID: NCT05700409 Recruiting - Obesity, Childhood Clinical Trials

Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The study objective is to evaluate whether a novel telemedicine-based intensive treatment program for children with obesity is superior to standard on-site care. This will be a randomized, non-blinded (due to the nature of the intervention) study, where 100 children and adolescents aged 10-18 years with obesity will be divided in a 1:1 ratio to either telemedicine or on-site treatments for 6 months. The telemedicine arm will include 30, mostly video, consultations for each participant: 3 physician appointments, 7 exercise consultations by our exercise physiologist, 10 dietary consultations by our pediatric dietitian, and 10 psychologist consultations to assist with goal setting and overall well-being. Three visits will be conducted in-office, for physician assessment, smartphone technical assistance and physical measurements (baseline, at 3 months and at the end of the 6-month period). Participants randomized to the telemedicine arm will have a step-counting rewarding app installed on their smartphone by our staff. The in-office arm will have 6 monthly visits during the study period, with two consultations performed in each visit - one by the physician or exercise physiologist, and one by our pediatric dietitian. The main outcome of the study is BMI standard deviation (z-score) changes, which will be evaluated after 3 and 6 months of treatment during physical office visits in both study arms. Secondary outcomes will be: - Body-fat percent changes, assessed by bioimpedance analysis in physical clinic visits. - Daily step counts, measured by smartphone data/ wearable activity tracker, if available. - Weight-related quality of life - Retention and visit cancellation rates. - Satisfaction of both parent and child from their allocated treatment.

NCT ID: NCT05671731 Completed - Obesity, Childhood Clinical Trials

Combining Prebiotic and Diet/Physical Activity Educational Program Effects on Body Composition and Intestinal Microbiota in Children

Start date: November 13, 2012
Phase: N/A
Study type: Interventional

The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses: H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention. H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores. Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed: RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention?

NCT ID: NCT05665621 Recruiting - Obesity, Childhood Clinical Trials

The Effects of Strength and Balance Training on Physical Function in Overweight Children

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question[s] it aims to answer are: - Is the school-based exercise programme effective in improving lower limb muscular strength and balance control? - How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks. Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.

NCT ID: NCT05648045 Active, not recruiting - Quality of Life Clinical Trials

Resilience and Obesity Prevention in Adolescents

Start date: February 20, 2023
Phase:
Study type: Observational [Patient Registry]

This is a cross-sectional observational study where investigators are trying to see the associations between factors contributing to obesity (dietary behavior and physical activity), resilience (self-efficacy, self-esteem, and optimism), and HRQoL in Indian adolescents. The key research question and sub-questions are as follows: Main research question: Is there a relationship between resilience (measured as self-efficacy) and obesity in children? 1. What is the level of other resilience factors (measured as self-esteem and optimism) among overweight, obese, and normal-weight adolescents? Are there differences between the groups? Are there differences between ages? Are there differences between genders? 2. Is there a relationship between resilience factors (measured as self-esteem and optimism) and HRQoL among overweight, obese, and normal-weight adolescents? Are there differences between the groups? Are there differences between ages? Are there differences between genders? 3. Is low resilience (measured as self-esteem, self-efficacy, and optimism) associated with overweight or obesity among adolescents and a lower HRQoL? Are there differences between ages? Are there differences between genders? 4. What is the level of association between resilience (identified as self-esteem, self-efficacy, and optimism) and factors contributing to obesity (dietary habits - measured in terms of more frequent unhealthy eating, such as eating fast food, sugary beverages, more calories, and less frequent healthy habits, such as more junk foods for meals, less physical activity, higher BMI, or higher weight-for-age Z scores, more body fat percentage and psychosocial factors related to obesity: socio-economic status

NCT ID: NCT05627011 Recruiting - Obesity, Childhood Clinical Trials

Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

iPOP-UP
Start date: February 9, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.

NCT ID: NCT05622981 Terminated - Obesity, Childhood Clinical Trials

Pediatric Obesity Management Study

Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Childhood obesity is a critical public health issue. Obesity in childhood is associated with many complications, including high blood pressure, type II diabetes mellitus, abnormal blood lipid values, obstructive sleep apnea, development of fatty liver, anxiety and depression. Addressing pediatric obesity is important not only to avoid these comorbidities in childhood, but also to mitigate long-term negative health outcomes, as overweight and obese youth are likely to remain overweight or obese into adulthood. There are published guidelines, however, there is not a successful standardized approach to the management of this problem. The most studied approach to pediatric obesity is multidisciplinary, high-resource weight management programs that are unable to be conducted in the primary care setting, and the prevalence of pediatric obesity continues to increase. The purpose of this study is to create, implement and evaluate a standardized protocol for the management of pediatric obesity in a low-resource primary care setting, using age-specific educational materials and every 2-week follow-up visits focused on achieving progress toward healthy lifestyle goals. The primary outcome will be the change in subject body mass index (BMI) percentile over 24 weeks of visits to the primary care doctor at a pediatric clinic.

NCT ID: NCT05595161 Recruiting - Obesity, Childhood Clinical Trials

Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings serving patients disproportionately affected by obesity.

NCT ID: NCT05563311 Completed - Clinical trials for Obstructive Sleep Apnea

Functional Assessment and Sleep Apnea in Obese Children and Adolescents

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Childhood obesity increases significantly, and determines several complications in childhood and adulthood, and the worldwide prevalence of childhood obesity has shown a rapid increase in recent decades. The severity of obesity-related risk factors is directly linked to body fat topography, and variations in body fat distribution in obese children can be of high value in predicting future health risks, like of cardiovascular disease in adulthood. There is a potential correlation between obesity and sleep disorders, increasing the predisposition to obstructive sleep apnea syndrome, that is a frequent complication, affecting up to 80% of obese children and adolescents. In relation to postural control, and that anthropometric indicators interfere with children's postural balance, already verified by balance assessment using computerized dynamic posturography. Several studies show that physical activity in childhood and adolescence can influence healthy habits in adulthood. Children and youth ages 5 to 17 should accumulate at least 60 minutes of moderate to vigorous-intensity physical activity daily. It is important to emphasize that the COVID-19 has impacted every aspect of healthcare delivery, and therefore Telerehabilitation has been satisfactorily addressed in reabilitation In the exercise recommendations for children, exercise programs performing aerobic and resistance exercises at a high level of intensity, on a frequent basis (3-5 days a week) for 30-80 minutes, seeking intensity of 50-90% of the maximum heart rate (HRmax), can be used and are shown to be efficient for the treatment of obesity. Therefore the High-intensity interval training (HIIT) describes physical exercise that is characterized by brief, intermittent bursts of vigorous activity, interspersed with periods of rest, cab generate favorable metabolic adaptations on sleep and body weight loss. Outcome Measures: Primary Outcome Measures - The effects of high-intensity interval training (HIIT) and high-intensity functional training (HIFT) through Telerehabilitation on body composition and Obstructive sleep apnea (assessed by body mass index and bioimpedanceand polysomnography type 4) Secondary Outcome Measures - Functional performance of children and adolescents (3 minute step test) - Balance (balance assessments with Wii Balance board) Inclusion Criteria: - Age ≥ 6 to 17 years; - Confirmed obesity children by body mass index acorrding to the age

NCT ID: NCT05556070 Active, not recruiting - Obesity, Childhood Clinical Trials

Brighter Bites & UT Physicians Produce Rx Program

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child)